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Asia-Pacific Journal of Oncology Nursing Dec 2023This study aims to explore the experiences and consequences of taste alterations in patients undergoing HSCT, how they respond to these changes, and the factors that...
OBJECTIVE
This study aims to explore the experiences and consequences of taste alterations in patients undergoing HSCT, how they respond to these changes, and the factors that influence their responses.
METHODS
In this descriptive qualitative study, face-to-face semi-structured individual interviews were conducted with 31 patients undergoing HSCT in a comprehensive hospital in Hubei, China. The interview data were transcribed and analyzed using Colaizzi's seven-step analysis. The Symptom Management Theory was applied to design the study and identify key themes.
RESULTS
Three key themes were identified from the theory: (1) the complexity and diversity of taste experiences; (2) coping strategies; and (3) the multifaceted challenges of coping. Taste alterations in HSCT patients were characterized by diversity and dynamism. Patients employed three distinct coping styles in response to taste alterations: active coping, reluctant submission, and passive coping. These coping styles were influenced by various factors, including the specific treatment modalities of HSCT, individual patient characteristics, and the healthcare environment.
CONCLUSIONS
The experience of taste alterations among HSCT patients is intricate and varied, and the importance of addressing this symptom can easily be underestimated. Management of taste alterations is influenced by multiple factors. Nursing staff should give careful attention to taste alterations in HSCT survivors, enhance their expertise in managing taste alterations, provide robust health education, conduct regular screening and assessments, and formulate individualized intervention plans to assist patients in actively and effectively managing taste alterations.
PubMed: 38033392
DOI: 10.1016/j.apjon.2023.100311 -
The Cochrane Database of Systematic... Nov 2023Oral nirmatrelvir/ritonavir (Paxlovid) aims to avoid severe COVID-19 in asymptomatic people or those with mild symptoms, thereby decreasing hospitalization and death. It... (Review)
Review
BACKGROUND
Oral nirmatrelvir/ritonavir (Paxlovid) aims to avoid severe COVID-19 in asymptomatic people or those with mild symptoms, thereby decreasing hospitalization and death. It remains to be evaluated for which indications and patient populations the drug is suitable.
OBJECTIVES
To assess the efficacy and safety of nirmatrelvir/ritonavir plus standard of care (SoC) compared to SoC with or without placebo, or any other intervention for treating COVID-19 or preventing SARS-CoV-2 infection. To explore equity aspects in subgroup analyses. To keep up to date with the evolving evidence base using a living systematic review (LSR) approach and make new relevant studies available to readers in-between publication of review updates.
SEARCH METHODS
We searched the Cochrane COVID-19 Study Register, Scopus, and World Health Organization COVID-19 Research Database, identifying completed and ongoing studies without language restrictions and incorporating studies up to 15 May 2023. This is a LSR. We conduct update searches every two months and make them publicly available on the open science framework (OSF) platform.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) comparing nirmatrelvir/ritonavir plus SoC to SoC with or without placebo, or any other intervention for treatment of people with confirmed COVID-19 diagnosis, irrespective of disease severity or treatment setting, and for prevention of SARS-CoV-2 infection. We screened all studies for research integrity. Studies were ineligible if they had been retracted, or if they were not prospectively registered including appropriate ethics approval.
DATA COLLECTION AND ANALYSIS
We followed standard Cochrane methodology and used the Cochrane RoB 2 tool. We rated the certainty of evidence using the GRADE approach for the following outcomes: 1. to treat outpatients with mild COVID-19; 2. to treat inpatients with moderate to severe COVID-19: mortality, clinical worsening or improvement, quality of life, (serious) adverse events, and viral clearance; 3. to prevent SARS-CoV-2 infection in postexposure prophylaxis (PEP); and 4. pre-exposure prophylaxis (PrEP) scenarios: SARS-CoV-2 infection, development of COVID-19 symptoms, mortality, admission to hospital, quality of life, and (serious) adverse events. We explored inequity by subgroup analysis for elderly people, socially-disadvantaged people with comorbidities, populations from low-income countries and low- to middle-income countries, and people from different ethnic and racial backgrounds.
MAIN RESULTS
As of 15 May 2023, we included two RCTs with 2510 participants with mild and mild to moderate symptomatic COVID-19 in outpatient and inpatient settings comparing nirmatrelvir/ritonavir plus SoC to SoC with or without placebo. All trial participants were without previous confirmed SARS-CoV-2 infection and at high risk for progression to severe disease. Randomization coincided with the Delta wave for outpatients and Omicron wave for inpatients. Outpatient trial participants and 73% of inpatients were unvaccinated. Symptom onset in outpatients was no more than five days before randomisation and prior or concomitant therapies including medications highly dependent on CYP3A4 were not allowed. We excluded two studies due to concerns with research integrity. We identified 13 ongoing studies. Three studies are currently awaiting classification. Nirmatrelvir/ritonavir for treating people with asymptomatic or mild COVID-19 in outpatient settings Nirmatrelvir/ritonavir plus SoC compared to SoC plus placebo may reduce all-cause mortality at 28 days (risk ratio (RR) 0.04, 95% confidence interval (CI) 0.00 to 0.68; 1 study, 2224 participants; low-certainty evidence) and admission to hospital or death within 28 days (RR 0.13, 95% CI 0.07 to 0.27; 1 study, 2224 participants; low-certainty evidence). Nirmatrelvir/ritonavir plus SoC may reduce serious adverse events during the study period compared to SoC plus placebo (RR 0.24, 95% CI 0.15 to 0.41; 1 study, 2224 participants; low-certainty evidence). Nirmatrelvir/ritonavir plus SoC probably has little or no effect on treatment-emergent adverse events (RR 0.95, 95% CI 0.82 to 1.10; 1 study, 2224 participants; moderate-certainty evidence), and probably increases treatment-related adverse events such as dysgeusia and diarrhoea during the study period compared to SoC plus placebo (RR 2.06, 95% CI 1.44 to 2.95; 1 study, 2224 participants; moderate-certainty evidence). Nirmatrelvir/ritonavir plus SoC probably decreases discontinuation of study drug due to adverse events compared to SoC plus placebo (RR 0.49, 95% CI 0.30 to 0.80; 1 study, 2224 participants; moderate-certainty evidence). No studies reported improvement of clinical status, quality of life, or viral clearance. Nirmatrelvir/ritonavir for treating people with moderate to severe COVID-19 in inpatient settings We are uncertain whether nirmatrelvir/ritonavir plus SoC compared to SoC reduces all-cause mortality at 28 days (RR 0.63, 95% CI 0.21 to 1.86; 1 study, 264 participants; very low-certainty evidence), or increases viral clearance at seven days (RR 1.06, 95% CI 0.71 to 1.58; 1 study, 264 participants; very low-certainty evidence) and 14 days (RR 1.05, 95% CI 0.92 to 1.20; 1 study, 264 participants; very low-certainty evidence). No studies reported improvement or worsening of clinical status and quality of life. We did not include data for safety outcomes due to insufficient and inconsistent information. Subgroup analyses for equity For outpatients, the outcome 'admission to hospital or death' was investigated for equity regarding age (less than 65 years versus 65 years or greater) and ethnicity. There were no subgroup differences for age or ethnicity. For inpatients, the outcome 'all-cause mortality' was investigated for equity regarding age (65 years or less versus greater than 65 years). There was no difference between subgroups of age. No further equity-related subgroups were reported, and no subgroups were reported for other outcomes. Nirmatrelvir/ritonavir for preventing SARS-CoV-2 infection (PrEP and PEP) No studies available.
AUTHORS' CONCLUSIONS
Low-certainty evidence suggests nirmatrelvir/ritonavir reduces the risk of all-cause mortality and hospital admission or death in high-risk, unvaccinated COVID-19 outpatients infected with the Delta variant of SARS-CoV-2. There is low- to moderate-certainty evidence of the safety of nirmatrelvir/ritonavir. Very low-certainty evidence exists regarding the effects of nirmatrelvir/ritonavir on all-cause mortality and viral clearance in mildly to moderately affected, mostly unvaccinated COVID-19 inpatients infected with the Omicron variant of SARS-CoV-2. Insufficient and inconsistent information prevents the assessment of safety outcomes. No reliable differences in effect size and direction were found regarding equity aspects. There is no available evidence supporting the use of nirmatrelvir/ritonavir for preventing SARS-CoV-2 infection. We are continually updating our search and making search results available on the OSF platform.
Topics: Humans; Aged; COVID-19; SARS-CoV-2; Ritonavir; COVID-19 Drug Treatment
PubMed: 38032024
DOI: 10.1002/14651858.CD015395.pub3 -
Archive of Clinical Cases 2023Smell and taste disturbances are potential adverse reactions of many drugs used in Psychiatry, such as antidepressants, anti-Parkinson agents, lithium, minor and major...
Smell and taste disturbances are potential adverse reactions of many drugs used in Psychiatry, such as antidepressants, anti-Parkinson agents, lithium, minor and major tranquilizers. To our knowledge, only one clinical case regarding valproate and cacosmia has been reported so far. However, several anticonvulsants are reported to cause taste and smell disturbances, although the underlying etiology is currently unclear. Our patient developed cacosmia and dysgeusia when taking valproic acid, both effects quickly disappeared upon drug discontinuation. In this article we not only report this uncommon side effect, but we discuss the plausible mechanisms behind such an adverse reaction. Our case is to date the second similar case in the literature. The aim of the present article is to make clinicians informed about this very uncommon and unpleasant side effect.
PubMed: 38026105
DOI: 10.22551/2023.41.1004.10265 -
Journal of Central Nervous System... 2023Current knowledge regarding coronavirus disease 2019 (COVID-19) is constantly evolving, and the long-term functional impairments, limitations, and restrictions have not...
Post-coronavirus disease 2019 functional impairments, limitations, and restrictions: A prospective cohort study based on the international classification of functioning, disability, and health.
BACKGROUND
Current knowledge regarding coronavirus disease 2019 (COVID-19) is constantly evolving, and the long-term functional impairments, limitations, and restrictions have not yet been well established.
OBJECTIVE
to evaluate the impact of post-COVID condition on the human functioning through the International Classification of Functioning, Disability and Health (ICF) classification.
METHODS
This is a prospective cohort study with 53 individuals with post-COVID condition at 3 time points: 0 to 3 (baseline), 3 to 6, and 6-12 months (follow-up). Outcomes were organized in dichotomous variable: No impairment (0); presence of impairment (≥1) in body function, structure, activities, and participation domains according to the ICF checklist. Chi-square test was used to determine the differences of 3 time points, and association with persistent symptoms.
RESULTS
A statistically significant difference was observed between the periods, with greater disabilities at 6-12 than at 0-3 months in mental, sensory, pain, and movement-related functions; cardiovascular, immunological, and respiratory systems. In terms of activity and participation, a greater limitation at 6-12 months was observed than at 0-3 months in learning and applying knowledge, general tasks, and mobility. In the domain of interpersonal interactions and relationships, there was a statistically significant difference between the 6-12 and 3-6 months groups. Associations between COVID-19 symptoms and ICF components at the first follow-up were: and with weight maintenance, and with pain, with watching and listening, with pain, and with pain, watching, and listening. At the second follow-up were: and with energy and drive functions, attention, memory, and emotional functions; with watching and listening; with emotional function, pain, undertaking multiple tasks, lifting and carrying objects, and driving; with energy and drive, emotional function, undertaking multiple tasks, lifting and carrying objects, and walking; with energy and driving, emotional function, respiration, muscle power, cardiovascular system, undertaking multiple tasks, lifting and carrying objects, and walking; and with emotional function, watching, and listening.
CONCLUSIONS
Individuals with COVID-19 persistent symptoms showed impairments in structure and function, activity limitations, and participation restrictions during the 1-year follow-up period.
PubMed: 38025402
DOI: 10.1177/11795735231195759 -
Revista Medica Del Instituto Mexicano... Nov 2023There are severe neurological conditions in patients with COVID-19, such as: cerebrovascular disease, Guillain-Barré syndrome, encephalitis, acute hemorrhagic... (Observational Study)
Observational Study
BACKGROUND
There are severe neurological conditions in patients with COVID-19, such as: cerebrovascular disease, Guillain-Barré syndrome, encephalitis, acute hemorrhagic necrotizing encephalopathy and myelitis.
OBJECTIVE
We describe that the patient with SARS-CoV 2 with respiratory symptoms has subtle or subclinical neurological manifestations.
MATERIAL AND METHODS
Observational, cross-sectional, analytical study, which included patients aged 18-65 years with respiratory symptoms and a confirmed diagnosis of COVID-19. Intubated patients with chronic neurodegenerative diseases or pre-existing neurological compromise were excluded. Semiology of the headache and neurological examination were performed; Serum levels of glucose, protein, electrolytes, lactate, C-reactive protein, lactic dehydrogenase, and D-dimer were measured. Cerebrospinal fluid (CSF) analysis and electroencephalogram (EEG) were also performed in patients who accepted the risks.
RESULTS
A high prevalence of subtle neurological manifestations was found in patients with COVID-19 with only a respiratory clinical picture. Headache, anosmia, dysgeusia, and hypopalesthesia predominated in the early stages, with frequent abnormal findings in the CSF (>70%) and less frequently in the EEG (<20%).
CONCLUSIONS
Headache, anosmia, dysgeusia and hypoesthesia were frequent at the beginning of the infection, together with abnormal findings in CSF and EEG, without other neurological symptoms or neurological disease.
Topics: Humans; SARS-CoV-2; COVID-19; Dysgeusia; Anosmia; Cross-Sectional Studies; Nervous System Diseases; Headache
PubMed: 37995329
DOI: 10.5281/zenodo.10064309 -
Clinical Cancer Research : An Official... Jan 2024Endocrine-based therapy is the initial primary treatment option for hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-)...
PURPOSE
Endocrine-based therapy is the initial primary treatment option for hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC). However, patients eventually experience disease progression due to resistance to endocrine therapy. Molibresib (GSK525762) is a small-molecule inhibitor of bromodomain and extraterminal (BET) family proteins (BRD2, BRD3, BRD4, and BRDT). Preclinical data suggested that the combination of molibresib with endocrine therapy might overcome endocrine resistance. This study aimed to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy [objective response rate (ORR)] of molibresib combined with fulvestrant in women with HR+/HER2- mBC.
PATIENTS AND METHODS
In this phase I/II dose-escalation and dose-expansion study, patients received oral molibresib 60 or 80 mg once daily in combination with intramuscular fulvestrant. Patients enrolled had relapsed/refractory, advanced/metastatic HR+/HER2- breast cancer with disease progression on prior treatment with an aromatase inhibitor, with or without a cyclin-dependent kinase 4/6 inhibitor.
RESULTS
The study included 123 patients. The most common treatment-related adverse events (AE) were nausea (52%), dysgeusia (49%), and fatigue (45%). At a 60-mg dosage of molibresib, >90% of patients experienced treatment-related AE. Grade 3 or 4 treatment-related AE were observed in 47% and 48% of patients treated with molibresib 60 mg and molibresib 80 mg, respectively. The ORR was 13% [95% confidence interval (CI), 8-20], not meeting the 25% threshold for proceeding to phase II. Among 82 patients with detected circulating tumor DNA and clinical outcome at study enrollment, a strong association was observed between the detection of copy-number amplification and poor progression-free survival (HR, 2.89; 95% CI, 1.73-4.83; P < 0.0001).
CONCLUSIONS
Molibresib in combination with fulvestrant did not demonstrate clinically meaningful activity in this study.
Topics: Humans; Female; Breast Neoplasms; Fulvestrant; Nuclear Proteins; Receptor, ErbB-2; Transcription Factors; Disease Progression; Antineoplastic Combined Chemotherapy Protocols; Bromodomain Containing Proteins; Cell Cycle Proteins; Benzodiazepines
PubMed: 37992310
DOI: 10.1158/1078-0432.CCR-23-0133 -
Scientific Reports Nov 2023It is not well-described how the acute symptoms of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) differ by variant, vaccination, sex and...
It is not well-described how the acute symptoms of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) differ by variant, vaccination, sex and age. A cross-sectional questionnaire study linked to national testing- and registry data was conducted among 148,874 SARS-CoV-2 first time reverse transcription polymerase chain reaction (RT-PCR) test-positive individuals and corresponding date-matched symptomatic test-negative controls. Major SARS-CoV-2 variants (Index/wild type, Alpha, Delta and Omicron) were defined using periods of predominance. Risk differences (RDs) were estimated for each of 21 predefined acute symptoms comparing: (1) test-positive and -negative individuals, by variant period, (2) vaccinated and unvaccinated test-positives, by variant period, (3) individuals tested positive during the Omicron and Delta periods, by vaccination status, and (4) vaccinated Omicron test-positive and -negative individuals, by age and sex. Compared to pre-Omicron, RDs between test-positive and test-negative individuals during the Omicron period were lower for most symptoms. RDs for altered sense of smell (dysosmia) and taste (dysgeusia) were highest for Delta (RD = 50.8 (49.4-52.0) and RD = 54.7 (53.4-56.0), respectively) and lowest for Omicron (RD = 12.8 (12.1-13.5) and RD = 11.8 (11.1-12.4), respectively). Across variants, vaccinated individuals reported fewer symptoms. During Omicron, females and 30-59 year-old participants reported more symptoms.
Topics: Female; Humans; COVID-19; SARS-CoV-2; Cross-Sectional Studies; Vaccination; Denmark
PubMed: 37964010
DOI: 10.1038/s41598-023-47273-8 -
Revista de Neurologia Nov 2023Headache is a frequent symptom at the acute phase of coronavirus disease 2019 (COVID-19) and also one of the most frequent adverse effects following vaccination. In both...
INTRODUCTION
Headache is a frequent symptom at the acute phase of coronavirus disease 2019 (COVID-19) and also one of the most frequent adverse effects following vaccination. In both cases, headache pathophysiology seems linked to the host immune response and could have similarities. We aimed to compare the clinical phenotype and the frequency and associated onset symptoms in patients with COVID-19 related-headache and COVID-19 vaccine related-headache.
SUBJECTS AND METHODS
A case-control study was conducted. Patients with confirmed COVID-19 infection and COVID-19-vaccine recipients who experienced new-onset headache were included. A standardised questionnaire was administered, including demographic variables, prior history of headaches, associated symptoms and headache-related variables. Both groups were matched for age, sex, and prior history of headache. A multivariate regression analysis was performed.
RESULTS
A total of 238 patients fulfilled eligibility criteria (143 patients with COVID-19 related-headache and 95 subjects experiencing COVID-19 vaccine related-headache). Patients with COVID-19 related-headache exhibited a higher frequency of arthralgia, diarrhoea, dyspnoea, chest pain, expectoration, anosmia, myalgia, odynophagia, rhinorrhoea, cough, and dysgeusia. Further, patients with COVID-19 related-headache had a more prolonged daily duration of headache and described the headache as the worst headache ever experienced. Patients with COVID-19 vaccine-related headache, experienced more frequently pain in the parietal region, phonophobia, and worsening of the headache by head movements or eye movements.
CONCLUSION
Headache caused by SARS-CoV-2 infection and COVID-19 vaccination related-headache have more similarities than differences, supporting a shared pathophysiology, and the activation of the innate immune response. The main differences were related to associated symptoms.
Topics: Humans; COVID-19 Vaccines; COVID-19; Case-Control Studies; SARS-CoV-2; Headache; Chest Pain
PubMed: 37962534
DOI: 10.33588/rn.7710.2023063 -
Nutrients Nov 2023Taste disorders are common among cancer patients undergoing chemotherapy, with a prevalence ranging from 20% to 86%, persisting throughout treatment. This condition...
Effect of Regular Consumption of a Miraculin-Based Food Supplement on Taste Perception and Nutritional Status in Malnourished Cancer Patients: A Triple-Blind, Randomized, Placebo-Controlled Clinical Trial-CLINMIR Pilot Protocol.
Taste disorders are common among cancer patients undergoing chemotherapy, with a prevalence ranging from 20% to 86%, persisting throughout treatment. This condition leads to reduced food consumption, increasing the risk of malnutrition. Malnutrition is associated not only with worse treatment efficacy and poor disease prognosis but also with reduced functional status and quality of life. The fruit of (Daniell), commonly known as miracle berry or miracle fruit, contains miraculin, a taste-modifying protein with profound effects on taste perception. The CLINMIR Protocol is a triple-blind, randomized, placebo-controlled clinical trial designed to evaluate the regular consumption of a food supplement containing a miraculin-based novel food, dried miracle berry (DMB), on the taste perception (measured through electrogustometry) and nutritional status (evaluated through the GLIM Criteria) of malnourished cancer patients under active antineoplastic treatment. To this end, a pilot study was designed with 30 randomized patients divided into three study arms (150 mg DMB + 150 mg freeze-dried strawberries, 300 mg DMB, or placebo) for three months. Throughout the five main visits, an exhaustive assessment of different parameters susceptible to improvement through regular consumption of the miraculin-based food supplement will be conducted, including electrical and chemical taste perception, smell perception, nutritional and morphofunctional assessment, diet, quality of life, the fatty acid profile of erythrocytes, levels of inflammatory and cancer-associated cytokines, oxidative stress, antioxidant defense system, plasma metabolomics, and saliva and stool microbiota. The primary anticipated result is that malnourished cancer patients with taste distortion who consume the miraculin-based food supplement will report an improvement in food taste perception. This improvement translates into increased food intake, thereby ameliorating their nutritional status and mitigating associated risks. Additionally, the study aims to pinpoint the optimal dosage that provides maximal benefits. The protocol adheres to the SPIRIT 2013 Statement, which provides evidence-based recommendations and is widely endorsed as an international standard for trial protocols. The clinical trial protocol has been registered at the platform for Clinical Trials (NCT05486260).
Topics: Humans; Taste Perception; Taste; Pilot Projects; Nutritional Status; Quality of Life; Fruit; Neoplasms; Dietary Supplements; Malnutrition; Randomized Controlled Trials as Topic
PubMed: 37960292
DOI: 10.3390/nu15214639 -
BMC Infectious Diseases Nov 2023While many studies on the determinants of post-COVID-19 conditions (PCC) have been conducted, little is known about the relationship between SARS-CoV-2 variants and PCC....
BACKGROUND
While many studies on the determinants of post-COVID-19 conditions (PCC) have been conducted, little is known about the relationship between SARS-CoV-2 variants and PCC. This study aimed to assess the association between different SARS-CoV-2 variants and the probability of having PCC three months after the infection.
METHODS
This study was a longitudinal cohort study conducted between April 2021 and September 2022 in Belgium. In total, 8,238 adults with a confirmed SARS-CoV-2 infection were followed up between the time of their infection and three months later. The primary outcomes were the PCC status three months post infection and seven PCC symptoms categories (neurocognitive, autonomic, gastrointestinal, respiratory, musculoskeletal, anosmia and/or dysgeusia, and other manifestations). The main exposure variable was the type of SARS-CoV-2 variants (i.e. Alpha, Delta, and Omicron), extracted from national surveillance data. The association between the different SARS-CoV-2 variants and PCC as well as PCC symptoms categories was assessed using multivariable logistic regression.
RESULTS
The proportion of PCC among participants infected during the Alpha, Delta, and Omicron-dominant periods was significantly different and respectively 50%, 50%, and 37%. Participants infected during the Alpha- and Delta-dominant periods had a significantly higher odds of having PCC than those infected during the Omicron-dominant period (OR = 1.61, 95% confidence interval [CI] = 1.33-1.96 and OR = 1.73, 95%CI = 1.54-1.93, respectively). Participants infected during the Alpha and Delta-dominant periods were more likely to report neurocognitive, respiratory, and anosmia/dysgeusia symptoms of PCC.
CONCLUSIONS
People infected during the Alpha- and Delta-dominant periods had a higher probability of having PCC three months after infection than those infected during the Omicron-dominant period. The lower probability of PCC with the Omicron variant must also be interpreted in absolute figures. Indeed, the number of infections with the Omicron variant being higher than with the Alpha and Delta variants, it is possible that the overall prevalence of PCC in the population increases, even if the probability of having a PCC decreases.
Topics: Adult; Humans; Longitudinal Studies; SARS-CoV-2; COVID-19; Belgium; Anosmia; Dysgeusia; Cohort Studies
PubMed: 37940843
DOI: 10.1186/s12879-023-08787-8